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| |  Diane-35 Available In Canada To Treat Severe Acne In Women TORONTO, ON -- Nov. 12, 1998 -- Berlex Canada Inc.’s Diane(R)-35, a new medication for women with severe acne and associated symptoms of androgenisation, including seborrhea (oily hair and skin) and mild hirsutism (excessive hair growth on body and face), is now available in Canada. Indicated for women who are unresponsive to oral antibiotics and other available treatments, Diane-35 is a unique combination anti-androgen/estrogen pill that also provides reliable contraception. "Acne and effects of other androgen-dependent dermatological conditions can have a severe and devastating impact on both the physical and psychologic health of a woman," says Dr. Kenneth Kobayashi, dermatologist, St. Mary's Hospital, Waterloo, ON. "Diane-35 can provide an effective means of controlling these conditions and thus restore a woman's self-esteem and greatly improve skin health and appearance. In addition, women have the security of knowing they are also using a reliable form of birth control." Androgens are male sex hormones that are also produced in smaller quantities in women and they are responsible for a number of actions including hair growth. When androgen activity is increased in women, conditions such as acne, seborrhea and hirsutism can result. These conditions are known as symptoms of androgenisation. "In addition to the changes in skin associated with androgenisation, other bodily changes toward male characteristics can occur," said Dr. Serge Belisle, chairman of the department of obstetrics and gynecology at the University of Montreal. "These include a deepening of the voice, enlargement of the clitoris and an increase in skeletal muscle. Diane-35 acts to reverse these conditions." Diane-35 contains two hormones: cyproterone acetate, a progestogen, and ethinyl estradiol, an estrogen. Cyproterone acetate inhibits the influence of androgens and reduces the activity of the sebaceous gland which plays an important role in the development of acne and seborrhea. "What's unique about Diane-35 is its ability to block androgen activity at the pilosebaceous unit," Belisle said. "While all oral contraceptives may decrease the production of androgens to some extent, only Diane-35 decreases the ability of androgens to bind to their receptors, improving signs of androgenisation such as acne, seborrhea and hirsutism in women. "Because Diane-35 contains both an estrogen and progestin, it provides extremely reliable contraception with good cycle control in patients treated for acne, seborrhea and hirsutism. It has many properties in common with other estrogen/progestogen combination oral contraceptives, meaning that the same contraindications and precautions applicable to this class of drugs should be considered." The recommended duration of treatment is at least several months, as improvement may not be observed until four or five cycles of use. Research has shown that within three to six months of therapy, acne can be improved and suppressed. It is recommended that a patient continue treatment for another three to four cycles after signs of androgen-related activity have subsided. "Women who require effective contraception can actually remain on Diane-35 as long as their physicians recommend," Dr. Belisle explained. "Diane-35 is as safe and efficacious as other oral contraceptives currently on the market, with 99.9 percent contraceptive reliability." Efficacy data from three pivotal clinical trials of Diane-35, including trials in Canada, demonstrates results from 1,462 women with symptoms of androgenisation, including severe acne, over a period of 23,549 cycles. In these trials, acne was improved in 38 percent of patients after three months and in 91 percent of patients after 12 months. Improvement was steady with progression of therapy and, by the end of 36 cycles, all cases of facial acne were completely healed. In these trials, associated symptoms of seborrhea and hirsutism, also showed a similar efficacy profile. By cycle nine, improvement of oily hair and skin was noted in 61 percent of the women taking Diane-35. While significant improvement in hirsutism was slower to occur, a trend towards improvement was observed consistently throughout the treatment period. After 36 cycles of therapy, hirsutism on the face, chest and abdomen, remitted in 60 percent, 95 percent and 82 percent of the patients respectively. Diane-35 tablets are available in 21-day blister packs. Overall, the drug is well-tolerated with reported adverse effects similar in nature and frequency to those reported with typical estrogen/progestogen combinations.
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